An interventional study of The AquaPass System in Chronic Heart Failure, Edema and CHF, sponsored by AquaPass Medical Ltd.. Completed at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by AquaPass Medical Ltd. · Not applicable, Interventional, and Treatment
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
This study will examine safety, performance and usability of the AquaPass device in two phases:
Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.
This study will examine safety, performance and usability of the AquaPass device in two phases:
Phase 1: Hospitalization treatment: This phase will begin when the patients are hospitalized with chronic heart failure symptoms and fluid overloaded and undergo sequential treatments. This phase will be conducted using a prospective case-control design, with measuring endpoint during hospitalization and follow-up (after discharge).
Phase 2: Home treatment: Upon investigator decision at discharge, patients will use Aqua-Pass device at home or at outpatient, after discharge, aiming to refine fluid management and prevent re-admission. This phase will require a separate Informed Consent Form (ICF) and will be conducted using a prospective single-group pre-post design.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 18 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →AquaPass Medical Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Subject is capable of meeting the following study requirements:
Subject completes 2 hours of run-in acclimatization session as follows:
Exclusion Criteria:
Phase 1: 'In Hospital' Phase: chronic heart failure (CHF) patients are enrolled in the study when admitted to the hospital with fluid overload. Study procedures performed, alongside diuretic therapy, in the hospital. Phase 2: 'At Home' Phase: Upon investigator's decision at discharge, the patients are enrolled in the second phase of the study for additional treatment sessions at home.
Device: The AquaPass System
The system is a non-invasive, multiple use device intended for use at the hospital, at the outpatient clinic settings or at home. The system administers warm, dry air around the patients' body in order to create environmental conditions that increase the patients' sweat rate. Throughout the treatment, fluids from the interstitial compartment are removed from the body by the eccrine sweat glands.
Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session
The primary performance endpoint for the in-hospital phase is the amount of fluid loss from sweat per treatment procedure (\~4h); the target rate of sweat production is \>500 ml/session in the in-hospital phase.
Time frame: In-Hospital Phase [2-10 days]
Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs
Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline
Time frame: up to 70 days
Change in body weight
To assess the effectiveness of the AquaPass System during the treatment phase patients will be assessed for their weight prior to the first treatment and after the last treatment
Time frame: Up to 60 days
Change of diuretic therapy
Documentation of changes in diuretics administration to assess safety and potential benefits with system use. (quantified by daily equivalent dose of furosemide).
Time frame: Up to 60 days
Changes in NT-ProBNP levels
Changes in NT-ProBNP levels to demonstrate the system's safety and performance
Time frame: Up to 60 days
Rate of Hospitalizations or emergency visits for decompensated heart failure
Documentation of CHF-related hospitalizations to assess safety and potential benefits with system use
Time frame: Up to 60 days
Changes in Renal function
Changes in blood electrolytes that are correlated with worsening of renal function
Time frame: up to 60 days
Change of quality of life as assessed by the KCCQ-12
Patients will be asked to complete the KCCQ-12 Questionnaire to evaluate their QoL during the study and assess the potential effect of the treatment on their well-being
Time frame: Up to 60 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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AquaPass Medical Ltd.